ARIA Radiation Therapy Management System (18.1)

The ARIA Radiation Therapy Management System (18.1) is a software application that enables authorized users to enter, access, modify, store, and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification, and treatment. It also stores treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. The system does not directly act on patients but is used by trained medical professionals to manage radiotherapy treatment information.

The subject device (v18.1) incorporates four software enhancements compared to the predicate device (v18.0): Dynamic Collimator Support, Multi-Institution capability, Integrated Patient Setup Documentation (CTH Integration), and Enhanced Calibration Curve Support. Varian characterizes these as enhancements rather than fundamental changes to the device's principle of operation.

ISO 14971:2019 (risk management), ISO 15223-1:2021 (symbols), ISO 20417:2021 (manufacturer information), IEC 62304:2006+A1:2016 (software lifecycle), IEC 62366-1:2015+A1:2020 (usability engineering), IEC 82304-1:2016 (health software safety), AAMI RT2:2017 (radiation therapy readiness), IEC 61217:2011 (radiotherapy equipment), IEC 62083:2009 (radiotherapy treatment planning systems), UL ANSI 2900-1:2017 and 2900-2-1:2017 (software cybersecurity), and IEC 81001-5-1:2021 (health software security).

Varian argues substantial equivalence based on three points: (1) the principle of operation remains identical to the predicate device; (2) software verification and validation testing demonstrates the subject device is as safe and effective as the predicate; and (3) the identified differences are enhancements rather than fundamental alterations to functionality. No clinical or animal studies were required, relying instead on non-clinical software V&V testing to support equivalence.